Laboratory Total Quality Management for Practitioners and Students of Medical Laboratory Science

By Erhabor Osaro and Adias Teddy Charles

This book will enable the production of reliable, accurate, reproducible (best possible care) results that satisfies the customers requirements obtained from an accredited, process oriented, health and safety conscious laboratory that is cost effectively run (value for money) by qualified, certified and highly motivated biomedical staff (Joy and pride at work) using well maintained, validated and quality controlled equipments and appropriately stored reagents on the right sample drawn from the right patient that is appropriately communicated in a timely fashion to the requesting clinician to enable them render the best possible evidenced- based medical care to their patients.

• Language: English
• Publisher: AuthorHouse UK
• Release date: Oct 9, 2012
• ISBN: 9781477231104

Erhabor Osaro

Dr Erhabor Osaro is a chartered scientist and fellow of the Institute of Biomedical Science of London. He holds a doctor of philosophy degree in immunohaematology. He completed the University of Greenwich specialist courses in blood transfusion and laboratory quality management system. His teaching experience spans both Nigeria and the United Kingdom. His work experience includes working as a Specialist Biomedical Scientist at the Royal Bolton Hospital-a continuous improvement conscious and a centre of excellence in the implementation of lean principle in the health sector in Europe. He is the recipient of several awards, including the famous British Blood Transfusion Society Young Scientist Award and the Margaret Kenwright Young Scientist Award. He is a registration portfolio verifier/examiner for the Institute of Biomedical Science of London. He is a member of the editorial board as well as an article reviewer for several scientific journals. A well-published contributor in the field of infectious diseases, immunohaematology, and transfusion medicine, he is chairman of the board of directors of Nelson Biomedical Limited, UK and Nigeria. He is married to Angela, and they are blessed with five children – Emmanuel, Majesty, David, Daniel, and Michelle. Dr Adias Teddy Charles is the provost of the Bayelsa State College of Health Technology, Ogbia, Nigeria. He holds a PhD in immunohaematology and is a fellow of the Institute of Biomedical Science (FIBMS), London. His current research interest is focused on transfusion immunology, safety and alternatives, and the haematology of infectious diseases. Recent publications have included articles in journals, such as the Journal of Blood Medicine, Transfusion Clinique et Biologique, Pathology, and Laboratory Medicine International, amongst others. Dr Adias is happy married and blessed with two children.

Book preview

Laboratory Total

Quality Management for

Practitioners and Students of

Medical Laboratory Science

Osaro Erhabor (Ph.D, FIBMS, CSci)

Associate Professor of Haematology and Transfusion Medicine Usmanu Danfodio University Sokoto Nigeria.

Teddy C Adias (Ph.D, FIBMS)

Provost, College of Health Technology, Bayelsa State, Nigeria

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AuthorHouse™

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© 2012 by Dr. Osaro Erhabor and Dr Adias Teddy Charles. All rights reserved.

No part of this book may be reproduced, stored in a retrieval system, or transmitted by any means without the written permission of the authors.

Published by AuthorHouse 11/15/2012

ISBN: 978-1-4772-3108-1 (sc)

ISBN: 978-1-4772-3109-8 (hc)

ISBN: 978-1-4772-3110-4 (e)

Library of Congress Control Number: 2012917760

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CONTENTS

Chapter 1   Who Is A Medical Laboratory Scientist And Principle Of Good Professional Practice

Chapter 2   Recruitment, Competence, And Appraisal Of Medical Laboratory Staff

Chapter 3   Quality Assurance And Continuous Quality Improvement

Chapter 4   Laboratory Quality Audits

Chapter 5   Introduction To Lean And Six Sigma Principles And Applications In The Laboratory

Chapter 6   Use Of A3 As A Quality Improvement Tool In The Laboratory

Chapter 7   Ethical And Medico-Legal Aspect Of Laboratory Science Practice

Chapter 8   Laboratory Quality Policy And Management Review Meeting Requirements

Chapter 9   Risk Analysis Of Sample Analysis Cycle

Chapter 10   Internal Quality Assessment (Iqa) And External Quality Assessment (Eqa)

Chapter 11   Performing Root Cause Analysis As A Problem Solving Tool In The Laboratory

Chapter 12   Laboratory Accreditation Process And Requirement

Chapter 13   Customer Satisfaction Surveys And Mission Statements

Chapter 14   Principle Of Good Laboratory Practice (Glp) And Its Application In The Diagnostic Laboratory

Chapter 15   Incident Reporting Procedure And Investigation In The Laboratory Medicine

Chapter 16   Role Of Laboratory Manager And Laboratory Management In The Offering Of A Quality Service

Chapter 17   Effective Laboratory Inventory Control Management Of Equipment, Reagents And Consumables

Chapter 18   Laboratory Information Management System (Lims)

Chapter 19   Product Development And Customer Satisfaction Issues Associated With The Laboratory

Chapter 20   Occupational Health Issues Associated With Working In The Laboratory

Chapter 21   Health And Safety Issues In The Laboratory

Chapter 22   Carrying Out Risk Assessment In The Laboratory

Chapter 23   Housekeeping Issues Associated With The Laboratory

Chapter 24   Psychological Hazards And Staff Morale-Related Issues Associated With Working In The Laboratory

Chapter 25   Document Control And Standard Operating Procedures

Chapter 26   Tips In Doing A Scientific Presentation

PREFACE

With the increasing emphasis on accountability within the public sector, the requirement to satisfy the accreditation criteria of several scrutinising regulatory bodies, and the need to meet the changing customer requirements, it is imperative that the laboratory as an organisation adopt a systematic approach to quality management issues. Hitherto the emphasis on achieving accreditation has meant that the concept of quality and quality systems in general have received less attention. However a properly managed quality system can form the framework to address many accreditation issues, as well as provide real opportunities for reducing waste, errors, enhancing staff morale, productivity, optimizing profitability and fostering a culture of continual quality improvement and customer satisfaction. This book amongst others will help practitioners and students in the field of medical laboratory science, other allied medical professions and medicine understand the peculiar role of laboratory total quality management in the delivery of a continually improving quality diagnostic service that meet customer and regulatory requirements as well as enhance the profitability of the laboratory as a business.

ACKNOWLEDGEMENTS

Our sincere thanks goes to AuthorHouse Publishers, for their assistance and contribution to the publication of this book; to our father in the Lord, Bishop David O. Oyedepo for being an inspiration in our lives through his teachings; to Pastor David Oladosu, Pastor Cyriacus Ekweme and Pastor T Davies for their spiritual oversight; to Chief Aibangbee Erhabor and Mrs Rose Erhabor; to Prof D.E. Agbonlahor, Prof O.A. Emeribe, Prof E.K. Uko, Prof O.A. Ejele, Prof C.A. Nwauche, Prof A. Ojule, Prof C. Akani, Prof S.D. Abbey, Prof R.A. Shehu, Prof L.S. Bilbis, Prof J Lori, Dr E.A.D. Alikor, Dr FI Buseri, Dr C Onwuka, Dr ZA Jeremiah, Dr A. Mainasara, Dr M.K. Dallatu, Dr H. Opurum and Mr O. Azuonwu for all their support and encouragement over the years. Our sincere thanks go to our families and friends for the encouragement while we wrote this book that will help build a culture of continuous quality improvement and create a quality consciousness among all those involved in diagnostic service delivery all over the world. To the Almighty God alone be all the glory.

CHAPTER 1

WHO IS A MEDICAL LABORATORY SCIENTIST AND PRINCIPLE OF GOOD PROFESSIONAL PRACTICE

Medical laboratory scientists or Biomedical Scientists work in healthcare to diagnose disease and evaluate the effectiveness of treatment through the analysis of body fluids and tissue samples from patients. They provide the engine room of modern medicine with 70% of diagnosis based on the laboratory results provided by laboratory scientists. Medical Laboratory Scientists are at the heart of the medical team providing other professionals with vital scientific information that allows them to make medical judgements needed for the effective management of the patient medical condition. When a major incident occurs, it is Medical Laboratory Scientists that ensure the right amount of blood reaches the right patient at the right time. We measure vital blood chemicals to monitor patient conditions and detect signs of internal bleeding, we determine coagulation analysis to determine patients prone to thrombosis and will require anticoagulation, we screen blood and blood product for transfusion to patients to ensure they are free from transfusion transmissible diseases, we carry out blood cultures to determine patients with septicaemia who require antibiotics treatment, we determine the specific antibiotics that is required to treat infective processes in patients and we study biopsies to determine if patients have cancers or are predisposed to cancers.

Without the important and life saving services provided by Medical Laboratory Scientists, accident and emergency wards would shut down, blood transfusion services will be unavailable, there will be inadequate management of hospital associated infections (MRSA), Coagulation clinics will be unable to provide thrombosis patients with anticoagulation, premature babies would struggle to survive without our support. Whenever you have a sample taken from you by a doctor or nurse, it is usually analysed by a biomedical scientist. Quite simply, without the services and support of these oracles of modern medicine, doctors would frequently be unable to diagnose diseases properly or treat patients effectively.

Registration requires completion of an academic degree plus a period of training in a any of the government-approved laboratory to enable them develop their practical skills and ensure their competence to allow for the protection of the vulnerable public and for patient safety. This may occur as part of an integrated degree (laboratory attachment) or may be completed post-graduation (Internship). The trainee’s progress and competence is recorded and should be assessed on completion of training. Trainees whose training meets the requirement of regulatory institute or council are registered and licensed to practice as a Medical Laboratory Scientist.

SPECIALISING IN THE FIELD OF MEDICAL LABORATORY SCIENCE

Training of the Laboratory Scientist is generic in the first 4 years of training and often covers a broad spectrum of courses in; haematology and blood transfusion, chemical pathology, immunology, histology, cytology medical microbiology, virology and parasitology.

image1.jpg

Figure: Field of specialisation in medical laboratory science

However in the final year of study the student medical laboratory scientist is expected to specialize in any of the field of speciality in medical laboratory science. They are usually expected to do specialist courses in their chosen field of speciality as well as carry out a research work and present a project report which is presented before a departmental examination board in the presence of an external examiner who is a specialist in the speciality. After qualifying as a Medical Laboratory Scientist, practitioners are expected to be actively involved in Continuous Professional Development (CPD) by carrying out a mixture of learning activities (attendance of seminars, workshops, paper presentation, book review, publication of articles and books, top up training, training of subordinate staff and other relevant training activities that is relevant to your work). Medical Laboratory Science is a dynamic science-based profession. The only way to be up-to-date is to engage in Continuous Professional Development.

MEDICAL MICROBIOLOGY

As a medical laboratory scientist in microbiology you will study micro-organisms such as bacteria, fungi and parasites which cause disease. You will identify these organisms and establish the antibiotic treatment required to effectively eliminate them therefore stopping the disease. Diseases diagnosed in the microbiology laboratory include meningitis, tuberculosis, gonorrhoea and other sexually transmitted diseases (STD’s) and food poisoning. Medical microbiology includes the study of microbial pathogenesis and epidemiology and is related to the study of disease pathology and immunology. In the medical laboratory, these microbiologists also work in a sub-department dedicated to parasitology. The discipline consists primarily of four major spheres of activity:

•   The provision of laboratory investigation, diagnosis, and treatment of patients suffering from infectious diseases.

•   The establishment and direction of infection control programs across the continuum of care.

•   Public health and communicable disease prevention and epidemiology.

•   The scientific and administrative direction of a diagnostic microbiology laboratory.

CHEMICAL PATHOLOGY

In clinical chemistry also known as chemical pathology, medical laboratory scientists analyse blood, body fluids and other biological materials to help in the diagnosis of diseases (such as renal failure, diabetes and liver diseases). They also carry out toxicological studies, carry out kidney and liver function test and help to monitor therapies. The discipline originated in the late 19th century with the use of simple chemical tests by medical Laboratory Scientists for various components of blood and urine. Subsequently other techniques were introduced including the use and measurement of enzyme activities, spectrophotometry, electrophoresis and immunoassay. Most current laboratories now use highly automated analyzers and use assays that are closely monitored and quality controlled. Chemical Pathology test are performed on any kind of body fluid, but mostly on serum or plasma. Serum is the yellow watery part of blood that is left after blood has been allowed to clot and all blood cells have been removed. This is most easily done by centrifugation which packs the denser blood cells and platelets to the bottom of the centrifuge tube, leaving the liquid serum fraction resting above the packed cells. Plasma is essentially the same as serum, but is obtained by centrifuging anticoagulated blood. Plasma therefore contains all of the clotting factors, including fibrinogen. The chemical pathology laboratory carry out a large array of tests that can be further sub-categorized into sub-specialties of:

•   General or routine chemistry

•   Endocrinology ( the study of hormones)

•   Immunology ( the study of the immune system and antibodies)

•   Pharmacology or Toxicology ( the study of drugs)

TRANSFUSION SCIENCE

In this discipline you will identify blood groups for blood donation, screen transfusion recipients for atypical antibodies, ensure the correct grouped blood is matched to the patient due to receive a red cell transfusion and make certain there is enough blood available in case of emergency such as road traffic accidents, operations and cancer treatments, screen donors for transfusion transmissible infections, screen patients for presence of alloantibodies, select antigen negative units for patients with alloantibodies. Manage stock levels of blood and blood products, prepare blood components (packed red cells, fresh frozen plasma (FFP), platelets and cryoprecipitate, stock and manage batch products like anti D for prophylactic use in Rhesus negative pregnant women, tranaxemic acid for the management of major haemorrhage and prothrombin complex concentrate (PCC) for the management of patients prone to thrombosis who are on anticoagulant therapy such as warfarin., carry out investigation for feto-maternal haemorrhage (FMH) in Rhesus negative women delivered of Rhesus positive babies to enable the effective dosing of prophylactic anti-D to prevent incidence of haemolytic disease of the foetus and newborn (HDFN) in subsequent Rhesus positive pregnancies as well as investigate transfusion reactions and other unexpected negative outcome associated with transfusion of blood and blood products.

HAEMATOLOGY

Haematology is the study of blood. In this discipline you will be involved with the formation, composition, functions and diseases of the blood. Some of the diseases diagnosed in haematology are leukaemia, malaria and anaemia. Haematology is concerned with the study of blood, the blood-forming organs, and blood diseases. Hematology includes the study of etiology, diagnosis, treatment, prognosis, and prevention of blood diseases. The laboratory work that goes into the study of blood is frequently performed by a medical laboratory scientist. Blood diseases affect the production of blood and its components, such as blood cells (red cells, white cells and platelets), haemoglobin, and blood proteins. Routine work in the Haematology laboratory includes routine complete blood count estimation, viewing blood films and bone marrow slides under the microscope, diagnosis of haemoglobinopathies, carrying out of coagulation investigations such as prothrombin time, APTT, Fibrinogen and D-Dimer, factor assays, thrombophilia screen, prothrombin gene variants and factor 5 Leiden for the management of hypercoagulable patients, patients prone to thrombosis on anticoagulant therapy and in determining patients predisposition to bleeding and interpreting various haematological test results. Hematology also includes specialist areas such as:

•   Diagnosis of bleeding disorders such as haemophilia and idiopathic thrombocytopenic purpura

•   Diagnosis of hematological malignancies such as lymphoma and leukemia

•   Diagnosis of haemoglobinopathies like sickle cell disease (SCD) and thalassaemia

•   Examination of bone marrow and stem cell transplantation

HISTOLOGY

In histology also called anatomical pathology, tissue samples are studied microscopically to establish the cause of illness. Tissue may be taken during surgery or at post mortem. Diseases such as cancer are diagnosed by looking for abnormal features in tissue cells. Anatomical pathology is a medical laboratory science specialty that is concerned with the diagnosis of disease based on the gross, microscopic, chemical, immunologic and molecular examination of organs, tissues, and whole bodies (autopsy).

CYTOLOGY

This discipline is often part of histology or anatomical pathology in most countries in Africa. However in most developed countries it is a speciality of its own. Cytology is best known for its work in screening cervical smears, but it also provides a non-gynaecological service. Like histology, specialised techniques are used to prepare and study samples of cellular materials. Cytology involves carrying out cervical screening programmes which involves cervical smears investigations to test women for the presence of cytological abnormalities in the cervix (neck of the womb) that can potentially develop into cancer. This test is performed regularly and routinely as a preventive measure to reduce mortality from cervical cancers.

VIROLOGY

Virology is the study of viruses and the disease caused by them such as German measles, HIV, Hepatitis B, Hepatitis C, Herpes Simplex virus and chickenpox. You will also be involved in monitoring the effects of vaccines. The virology laboratory also performs your viral studies, experimentation, testing, analysis and research. Virology is becoming increasingly complex, rapidly developing in areas such as nucleic acid technology, antiviral chemotherapy, new viral vaccines, identification of new human viruses, and management of infection control problems in both the hospital and local community.

IMMUNOLOGY

Medical Laboratory scientists in immunology deals with the body’s immune system and its role in infectious diseases, parasitic infestations, allergies, tumour growth, tissue grafts and organ transplants. Their work is particularly important in the monitoring and treatment of patients living with HIV and AIDS. Medical laboratory science is an evolving science moving into new areas such as cytogenetics and molecular biology.

CYTOGENETICS

Cytogenetics involves the processing and analysis of the chromosomes of different types of sample with the purpose of detecting and interpreting chromosomal abnormalities. Five decades ago the first recognized the correct chromosome number in man was said to be 46. Shortly thereafter, several chromosome aneuploid syndromes were identified. In the early 1970s, various chromosomal-banding techniques were developed that allowed the recognition of individual chromosomes and deletions and duplications as aetiologies for numerous chromosome syndromes. The roles of a cytogeneticist include:

•   Analysis of blood from individuals from a variety of chromosomal syndromes such as congenital abnormalities, learning difficulties, reproductive difficulties and sexual development-related problems.

•   Prenatal diagnosis of chromosomal abnormalities such as Down’s syndrome from the amniotic fluid or chorionic villus samples.

•   Analysis of bone marrow and blood samples from patients with haematological malignancies such as leukaemia to aid diagnosis ans management.

MOLECULAR BIOLOGY

Molecular biology is the branch of biology that deals with the molecular basis of biological activity. This field overlaps with other areas of . and chemistry, particularly genetics and biochemistry. Molecular biology chiefly concerns itself with understanding the interactions between the various systems of a cell, including the interactions between the different types of DNA, RNA and protein biosynthesis as well as learning how these interactions are regulated.

PRINCIPLE OF GOOD PROFESSIONAL PRACTICE

It is the responsibility of every regulatory laboratory professional body to provide information (good professional practice) to help her members practice safely and effectively in the interest of the vulnerable public. Good professional practice outlines how, as a profession, medical laboratory science can aim to provide the highest quality of service to ensure that patients and clients get the best possible diagnostic service and care. It defines the level of practice expected from every medical laboratory scientists and their duty of care they have to patients as well as their responsibilities to professional colleagues, other healthcare professionals and the profession. Medical laboratory science is an important part of the medical family. Several health professionals work as a team to provide patients with the best possible medical service. Good Professional Practice also provides information on additional professional and specific guidance provided by the regulatory professional bodies. First and foremost practising medical laboratory scientists must abide by the legal and statutory requirements regulating the profession. Failure to do so could result in a scientist being suspended or removed from the institute and council’s register. Medical laboratory scientist should note that failure to adhere to legal requirements of practice and recommended principles of professional good practice could affect an individual’s cover under the council professional indemnity insurance scheme, and may result in expulsion from the council register.

CODE OF CONDUCT FOR LABORATORY SCIENTIST

The ethical framework within which medical laboratory scientists should practise is concerned with:

•   Professional competence

•   Personal conduct

•   Professional relationships with other healthcare colleagues

•   Public duties ( confidentiality, honesty, diligence, integrity).

All members of the Medical Laboratory Science profession shall always:

•   Exercise their professional knowledge and skill with judgement and care for the benefit of the vulnerable wider general public and in the best interests of the users of the service.

•   Demonstrate the highest standards of conduct, honesty and integrity in their personal and professional behaviour.

•   Understand, recognise and work within the limits of their professional knowledge, skills and experience.

•   Recognise the beliefs and values of the wider general public, the users of the service and professional colleagues, treating them on a fair and equitable basis.

•   Ensure their own beliefs and values do not prejudice or compromise their ability to carry out their professional roles and duties.

•   Maintain, improve and keep up-to-date their professional knowledge and skills.

•   Aid and support the development of medical laboratory science by education or training of their professional colleagues, the users of the service and the wider general public.

•   Promote the study and activity of laboratory science by promotion of the values, aims and objectives of the regulating council or institute.

•   Be involved in continuing professional development (CPD) as a way of being up-to-date in their professional knowledge and skills.

•   Promote the aims, objectives and values of the profession.

Usually failure by a member of a professional group to abide by the code of conduct of an organization can result in the member being struck off the profession’s register

PROFESSIONALS INVOLVED IN THE HOSPITAL AND DIAGNOSTIC LABORATORY

There are a variety of skilled and educated laboratory professionals who you may never encounter as a patient. However, these individuals play a very important role in diagnostic service delivery. People working in the diagnostic laboratory are responsible for conducting tests that provide crucial live saving information to the clinician. Apart from detecting the presence of infective agents, they are also involved in disease monitoring, research and public health. These skilled professionals use specialized equipment and techniques to analyze patients’ samples, such as blood, urine, body fluids, tissue, and stool. They may be working in the hospital, clinic or a reference laboratory. Professionals involved in laboratory include medical laboratory scientist, laboratory technicians and laboratory attendants. Biomedical scientists work and supervise a complex mix of professional staff groups who they interact and work with in delivering quality diagnostic laboratory services. They include scientific, technical and support staff (laboratory technicians, attendants, phlebotomy staff, secretarial and administrative staff. The medical laboratory science profession is regulated by the Institute of Biomedical Science in the case of the UK. In most countries the diagnostic laboratory is headed by the Assistant Director of Medical Laboratory Services or the Chief Medical Laboratory Scientist who is in charge of the day to day running of the laboratory (budgeting, planning inventory control, personnel management and training). The laboratory scientist manages other subordinate staff in the laboratory (laboratory technicians, attendants, trainees, phlebotomy staff and secretarial staff). They manage the laboratory revolving funds and ensure an uninterrupted delivery of a continually improving quality diagnostic service that meet the needs of the laboratory customers. Other categories of an autonomous professional group that work in the laboratory are pathologists. They are clinician whose training is regulated by Royal College of pathologist as in the UK or the Medical and Dental Councils. This cadre of laboratory professions have a parallel organogram. They are responsible for managing patients with conditions in the area of specialty using results generated by laboratory scientist, running their clinics, training of their residents as well as talking consult from their medical colleagues and managing their clinical laboratory budget. However, there has been a widespread breakdown in working relationships between biomedical scientists or laboratory scientist in most countries because of the failure of the pathologist to appreciate the fact that both professions are autonomous even though they work as a team to ensure that patients receive the best possible diagnostic service.

CHAPTER 2

RECRUITMENT, COMPETENCE, AND APPRAISAL OF MEDICAL LABORATORY STAFF

RECRUITING THE BEST MEDICAL LABORATORY STAFF FOR YOUR TEAM

In theory, recruitment should be simple. Many managers perform the same routine: they write a job description put an advertisement in the newspaper or online, wait for applicants to apply, and then hire the person they deem fit for the job. Care is required to ensure that the selected candidate is likely to get on with the rest of the team, is in tune with the organization’s continuous improvement culture, and is likely to stay with the organization rather than get employed, become fully trained, and immediately leave to work for another organization. Recruitment mistakes waste time, money, and organizational resources, and they can really hold a team back. Organizations must realize that it is not just a function of employing the best candidate for a job; it is also their responsibility that staff welfare and motivation is taken seriously. Staff members who are not motivated are likely to be less productive and are more likely to seek greener opportunities elsewhere.

EFFECTIVE RECRUITMENT (WHAT A LABORATORY MANAGER MUST LOOK OUT FOR)

There are several reasons why it is extremely important that recruitment is done properly.

•   The right people in the right roles will be more productive. Employing the right persons for the right roles is critical if an organization must be productive and result-oriented. The right persons are not likely to leave the organization. High staff turnover is a serious problem that can put a lot of stress on staff on the ground and can affect morale

Reviews for Laboratory Total Quality Management for Practitioners and Students of Medical Laboratory Science

[Emmett Gourdine · Rating: 5 out of 5 stars]

Very comprehensive! A good reference document for laboratory managers to always have available.